HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936

K062245 · Hardy Diagnostics · JTN · Aug 23, 2006 · Microbiology

Device Facts

• Record ID: K062245
• Device Name: HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
• Applicant: Hardy Diagnostics
• Product Code: JTN · Microbiology
• Decision Date: Aug 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

HardyDisk® Tigecycline Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer). Zone sizes used for interpretation of tests and control organism limits were determined by the drug manufacturer and received FDA approval under NDA Number 21-821.

Device Story

HardyDisk Tigecycline, 15 µg, is an antimicrobial susceptibility test disk used in clinical microbiology laboratories. The device consists of paper disks impregnated with a specific concentration of the antibiotic tigecycline. In the agar diffusion (Kirby-Bauer) test procedure, the disk is placed on an agar plate inoculated with a bacterial culture. As the antibiotic diffuses into the agar, it creates a concentration gradient. After incubation, the zone of inhibition around the disk is measured. The size of this zone is compared against established interpretive criteria to determine the susceptibility of the microorganism to the antibiotic. This information assists clinicians in selecting appropriate antimicrobial therapy for patients.

Clinical Evidence

No clinical data provided. The device relies on established interpretive zone size criteria determined by the drug manufacturer and approved under NDA 21-821.

Technological Characteristics

Paper disks impregnated with 15 µg of tigecycline. Operates via passive diffusion in agar media. Standardized for Kirby-Bauer agar diffusion susceptibility testing.

Indications for Use

Indicated for semi-quantitative in vitro antimicrobial susceptibility testing of microorganisms using the agar diffusion (Kirby-Bauer) method.

Regulatory Classification

Identification

An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## AUG 2 3 2006

Mr. Andre Hsiung Director of Technical Services/R&D Hardy Diagnostics 1430 W. McCoy Lane Santa Maria, California 93455

k062245 Re:

> Trade/Device Name: HardyDisk Tigecycline, 15 µg Regulation Number: 21 CFR § 866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: II Product Code: JTN Dated: July 28, 2006 Received: August 7, 2006

Dear Mr. Hsiung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally, attorn

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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YOUR MICROBIOLOGY SPECIALIST FOR 25 YEARS AND COUNTING

## Indications for Use

K062245 510(k) Number (if known):

Device Name: HardyDisk Tigecycline, 15 µg

Indications for Use:

HardyDisk®1 Tigecycline Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer). Zone sizes used for interpretation of tests and control organism limits were determined by the drug manufacturer and received FDA approval under NDA Number 21-821.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Salazar

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k062245

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Headquarters & Customer Service
1430 West McCoy Lane
Santa Maria, CA 93455

phone: [phone]
fax: [phone]
email: sales@hardydiagno
web: www.hardydiagnostic

**Distribution Centers:**

Phoenix, Arizona
[phone]

Salt Lake City, Utah
[phone]

Tacoma, Washington
[phone]

Lima, Ohio
[phone]